- Takeda Pharmaceuticals (Boston, MA)
- …as a strategic advisor and technology domain expert for Pharmaceutical Sciences/ CMC scientific and clinical manufacturing informatics and digital solutions + ... business partner leadership role. + Proven track record in delivering enterprise-scale CMC technologies and digital solutions in a GxP-regulated environment. + Deep… more
- Takeda Pharmaceuticals (Lexington, MA)
- …CMO and vendors, works closely with drug product, quality, regulatory , program leadership, etc. and establish strategic working relationships. **Responsibilities:** ... plans as required. + Evaluates impact of decisions across CMC functions. + Makes significant independent contributions to complex...plus. + Proven track record of developing and gain regulatory approval of drug delivery systems a plus +… more
- Bristol Myers Squibb (Cambridge, MA)
- …late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision ... for both internal and external opportunities. + Participates in regulatory filings (NDA, BLA filings) as well as develops...evidence. + Supports commercial needs and recommendations to guide CMC and GPS on trade packaging and commercial product.… more
- Sanofi Group (Framingham, MA)
- …support MSAT programs and global manufacturing sites, and to collaborate with R&D/ CMC teams. + Lead complex manufacturing investigation such as large column packing ... manufacturing staff at pilot facility. Work with MSAT and CMC pilot teams to drive the necessary pilot data...Internal and external manufacturing sites + Support Quality and Regulatory during health authority inspection and prepare for supportive… more
- Sanofi Group (Waltham, MA)
- …support in R&D for pre-clinical work, bioassay and biomarker research and/or CMC , biological assay, and biomarker research. He/She will work in close collaboration ... accurate assessments are made for decision-making, while ensuring compliance with regulatory expectations. **Main responsibilites** Acts as the lead statistician and… more
- Amgen (Cambridge, MA)
- …leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products. Drug Product Team ... integrated development of combination products, process improvements, life cycle changes, regulatory submissions, annual product reviews, etc. DPTLs are part of an… more
- Sanofi Group (Cambridge, MA)
- …skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical ... of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The...organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device … more
- Takeda Pharmaceuticals (Lexington, MA)
- …of regulatory guidance and industry standards relevant to analytical CMC activities, particularly in the development and validation of potency assays + ... from Research, Quality Control, Process Development, Drug Product Development, and Regulatory Affairs to drive alignment on potency strategy and successful transfer… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- …endpoints ensuring seamless integration across discovery, nonclinical, clinical pharmacology, regulatory , and commercial functions. As an industry-leading expert and ... not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs, Global Clinical Development (late phase), Data & Analytics, Early… more
- Alloy Therapeutics (Waltham, MA)
- …from research scale to GMP production, ensuring robustness, reproducibility, and regulatory compliance. + Implement Quality by Design (QbD) principles to establish ... and finished product quality control, aligning with internal standards and regulatory expectations. Oligonucleotide Design & Chemical Innovation + Lead the design… more